Device for laceration or incision closure

ABSTRACT

Disclosed is a two-component device for closing a laceration or incision. The device includes a first component comprising a first adhesive-backed anchoring member and one or more first connecting members extending from one edge thereof in a first direction. Also included is a second component comprising a second adhesive-backed anchoring member and one or more second connecting members extending from one edge thereof in a second direction generally opposite to the first direction. Means for attaching the one or more first connecting members to the second anchoring member and means for attaching the one or more second connecting members to the first anchoring member is also provided. The attachment of the connecting members to the anchoring members forms attached and bridging portions of the one or more connecting members, the attached portions being attached to an anchoring member, and the bridging portions spanning the over-laceration area between the first and second anchoring members. The first and second components disclosed are transparent, so that visual inspection of the laceration can be achieved subsequent to application of the device. Methods of use are also disclosed.

BACKGROUND OF THE INVENTION

Devices and methods for laceration or incision closure are known in theart. The use of sutures, staples or clamps to close a laceration orincision represents the most common of these prior art techniques. Theuse of sutures, staples or clamps is an invasive technique that can bepainful and requires the use of an anesthetic. These processes oftenleave unsightly scars, both from the insertion holes and from varyingtensions applied to the laceration or surgical incision between suturingpoints and intervening spaces. Moreover, these methods necessitatefollow-up visits to a hospital or doctor's office for removal.

Although other devices and methods for closing lacerations or incisionsare known in the art, these have not gained popular acceptance due tolimitations in their design. There is a clear need for non-, or lessinvasive methods for laceration or incision closure which is practicaland easy to use.

SUMMARY OF THE INVENTION

The present invention relates to a two-component device useful forclosing a laceration or incision. The first component of the deviceincludes an adhesive-backed anchoring member, and one or more firstconnecting members extending from a first edge of the anchoring member.The first edge of the anchoring member is also referred to herein as awound edge because, in use, the first edge is placed along one edge ofthe laceration or incision. The connecting members are, generallyspeaking, elongated and strap-like in configuration. That is, the widthof the connecting members is substantially greater than their thickness.The second component of the device also includes an adhesive-backedanchoring member, and one or more connecting members extending from afirst edge of the anchoring member of the second component of thedevice. As was the case with the first component of the device, thefirst edge of the anchoring member of the second component is alsoreferred to herein as a wound edge.

The first and second components of the device are generally producedfrom sheets or rolls of a polymeric material, or a polymeric composite.The sheet or roll stock is typically referred to as “film” as thethickness of the stock in preferred embodiments ranges from about 0.5mil to about 5 mil. As is discussed in greater detail below, the firstand second components may be produced individually as monolithiccomponents (having no joints or seams). Such monolithic components areproduced from single stock material. This stock must be substantiallyinelastic, as any stretching which could allow the laceration orincision to open is clearly undesirable. Alternatively, polymericmaterials which are elastic may be used if they are reinforced with aninelastic structural material. Such reinforced polymers are referred toherein as polymeric composites. A reinforcing, inelastic structuralmaterial is referred to in the art as “scrim.” Scrim may be a woventextile or polymer, a non-woven polymer or any other structural entitythat acts to stabilize the substrate. Preferably, the scrim reinforcedsubstrate will have a high degree of air permeability (e.g., 1,000 to8,000 liters/sec/m²).

Additionally, non-reinforced polymers exhibiting a degree of elasticitymay be used in the production of anchoring members for embodiments inwhich anchoring members and connecting elements are produced separately,and subsequently attached. If a non-reinforced elastic polymer is usedto produce an anchoring member, it will be preferable to reinforce theupper surface of the wound edge with an inelastic element so that woundedge remains substantially straight across the incision site during theclosure process. Such an element is referred to herein as a “wound edgebar.” Vapor permeable polymeric materials that satisfy the otherrequirements for use in the manufacture of the device offer improvedcomfort and are preferred. Transparent stock is also preferred so thatthe healing process of the entire wound site can be monitored easily.

The first and second components are cut from sheet stock by anyconventional process. Die cutting from sheet or roll stock is one methodthat may be employed. Laser and ultrasonic trimming devices are alsoexamples of equipment that may be used to cut the components of thepresent invention.

The specification of a particular device such as the size of theanchoring members, and length and width of connecting members, isdictated primarily by functional considerations. For example, a surgicalprocedure such as a Cesarean-section is a procedure for which a highdegree of security in closure would be of primary concern. The abdomenprovides a large surface for adhesive attachment, and anchoring membersand connecting members would be over-sized to provide a high degree ofsecurity. The practical limits to over-sizing the components aredictated only by skin surface available for effective attachment. Thus,for a Cesarean-section, an anchoring member extending from the point ofincision, around to the back of the individual could be used. For smalllacerations in visible locations, such as the face, very small anchoringmembers (e.g., ¼ inch by ½ inch) may be appropriate. Although it isconvenient for manufacturing purposes, there is no requirement forsymmetry in the device of the present invention. That is, the anchoringmember of the first component need not be identically shaped to that ofthe second component. Furthermore, it is not a requirement of the devicethat the first and second components have the same number of connectingmembers or be produced from the same sheet stock.

Devices of the present invention are easily cut and trimmed for secureapplication. For example, the anchoring member of one component may betrimmed to avoid application to an area where such application wouldinevitably result in a lifted-adhesive edge which could result inpremature release of the entire device.

A number of embodiments of the device are disclosed herein. Features ofparticular importance include: the use of transparent stock for theproduction of the first and second components; the selective applicationof adhesive to portions of the lower surfaces of connecting members;connecting members having less average width in the bridging portionrelative to the attached portion; the use of a two-stage release linersystem; and the separate production of connecting members and anchoringmembers followed by attachment to form individual first and secondcomponents. A device of the present invention may contain one or more ofthe disclosed features, in any combination thereof. These features willbe discussed in greater detail below.

The adhesives selected for use in connection with the present inventionmust meet a number of requirements. First, adhesive which is to comeinto contact with the skin must be selected to minimize the potentialfor adverse reaction by the skin. That is, the adhesive selected shouldbe hypoallergenic. Additionally, all adhesives, whether or not they areintended to contact the skin, must provide a secure hold for a period oftime sufficient for the healing process to progress to the point whereremoval of the device is appropriate. An adhesive hold period of about7–10 days is generally suitable.

The use of the device to close a laceration or incision will bediscussed in greater detail below, however, a brief orientation at thisstage in the discussion is helpful. In use, the adhesive-backedanchoring member of the first component of the device is applied to theskin of the animal or human patient adjacent to the laceration orincision to be closed. The device of the present invention is producedin a variety of sizes, or may be used in series, to close lacerations orincisions of varying lengths. The wound edge of the first component isplaced very near to the edge of the laceration or incision, but not soclose as to introduce adhesive from the first component anchoring memberinto the open area of the laceration or incision. The one or moreconnecting members extend from the wound edge of the anchoring member ofthe first component, in a direction which is generally perpendicular tothe wound edge, and extend across the area of a laceration or incisionto the opposite side of the laceration.

A similar application procedure is followed for application of thesecond component, the procedure for the application of the second beingthe mirror image of the procedure for application of the first.Following application of the anchoring members, the laceration is closedby either pushing anchoring members toward one another, or by pullingthem together by grasping one or more connecting members from eachcomponent and pulling the laceration closed. Very fine adjustment can bemade in the X and Y dimension ensuring laceration closure with minimalscarring. When the first and second component are positioned to thesatisfaction of the physician, or other individual applying the device,the relationship of the two components is fixed by attaching the one ormore connecting members of the first component to the anchoring memberof the second component, and by attaching the one or more secondconnecting members of the second device to the anchoring member of thefirst device.

Adhesive is a preferred means of attaching one or more connectingmembers to an anchoring member. In one embodiment, adhesive is appliedto at least a portion of the lower surface of the connecting members forattaching the connecting members of one of the two components to theapplied anchoring member of the other component. The connecting membershave two parts or portions—an attached portion and a bridging portion.The attached portion of the connecting members, as the name indicates,is that portion which is attached to the anchoring member of theopposing component following application of the device. The bridgingportion is the portion of the connecting member or members which spansthe over-laceration area. In further refined embodiments, the lowersurface of the bridging portion contains less adhesive than the attachedportion. In preferred embodiments, the entire bridging portion of theone or more connecting members are free of adhesive or alternately haveadhesive, but this is blocked with another film (kill layer) to renderthe adhesive in the bridging portion nonfunctional.

As mentioned above, the dimension of the connecting members isstrap-like in that their width is substantially greater than theirthickness. In light of the fact that the point of attachment between thefirst and second components is between the underside of attachedportions of connecting members with the upper surface of attachedanchoring members, maximizing the area of contact will result in a moresecure closure of the device because the area of adhesive contact ismaximized. Thus, from the standpoint of security of closure, widerconnecting members are preferred. However, as the width of all theconnecting members is increased, the distance between connecting membersnecessarily is decreased. It is extremely important that there be enoughdistance between adjacent connecting members to facilitate fineadjustment of the device as the second anchoring member is beingpositioned, and after the two anchoring members are positioned, butprior to fixing their relationship by attaching connecting members toanchoring members.

As was stated in U.S. Pat. No. 6,329,564, the disclosure of which isincorporated herein by reference:

-   -   There is no absolute minimum which can be stated with respect to        spacing between elongated connectors [connecting members].        Preferred ranges are probably best stated as a percentage of        device length (i.e., the dimension of the device generally        parallel the laceration or incision). For example, a spacing of        between about 5% to about 10% of the bandage length is an        example of an appropriate range.

This spacing provides substantial adhesive contact between attachedportions of connecting members with anchoring members, as well assufficient spacing for fine adjustment of both before and following theattachment of the second anchoring member. Fine adjustment made afterthe attachment of the second anchoring member is generally a concernafter the laceration has been closed and just prior to attachment ofconnecting members to anchoring members. At this stage in theapplication process, the bridging portions of the one or more firstconnecting members and the bridging portions of the one or more secondconnecting members are aligned with one another over the closedlaceration or incision. In a preferred embodiment of the presentinvention, the average width of the bridging portions is less than theaverage width of the attached portions of the connecting members.Average width is determined by measuring from the outer perimeters ofthe bridging portions and the outer perimeters of the attached portions.

This difference in width in the bridging portion relative to theattached portion affords advantages over prior art devices in which thewidth of connecting members was substantially constant along theirlength. Consider, for example, a prior art device designed for maximumsecurity. In such a device, the connecting members would be placed asclose as possible, while still providing for a minimum acceptable degreeof adjustment range. If the bridging area were narrowed in such adevice, the net effect would be an increase in exposed area over thelaceration (which is desirable for application of medicines, removal ofexudates, etc), as well as an increase in the range of adjustment(narrowing the width of the connecting members in the bridging portioneffectively increases the distance between adjacent bridging portions).

Considering the same prior art device discussed in the precedingparagraph, holding the width of bridging portion constant, whileincreasing the width of the attached portions provides for greatersecurity as the area of adhesive contact is effectively increased. Itwill be recognized by one skilled in the art that hybrid configurations(i.e., devices having narrowed bridging portions and widened attachedportions relative to prior art, uniform width devices) representimportant embodiments of the present invention.

Preferred embodiments of the present invention include pulling elementswhich are attached to connecting members, or to extensions of connectingmembers. Extensions of connecting members could themselves be consideredto be pulling elements in embodiments in which only one connectingmember is associated with a component. By definition, the attachedportion of a connecting member attaches to the anchoring member ofanother component. Extensions of a connecting member extend the lengthof the connecting member for ease of application, and are generallyremoved following the application process. Perforations are preferablyprovided to facilitate their removal. For embodiments in which thenumber of connecting members associated with a component is greater thanone, a pulling element is useful for joining the connecting members orextensions of connecting members to enable a user to easily apply apulling force to more than one connecting member.

To minimize confusion for new users of the device of the presentinvention, the pulling elements and anchoring members may be coded toenable user distinction. Thus, for example, the coding may comprise anobservable geometric distinction between the shape of the pullingelements and the shape of the anchoring members. In another embodiment,such coding may comprise printed indicia to enable user distinctionbetween the components. Colors may also be used to provide thisdistinguishing function.

The device of the present invention includes a minimum of one connectingmember associated with each component of the two-component device. Forembodiments in which each component includes two or more connectingmembers, and the connecting members are attached to pulling elements,the issue of interlacing the connecting members of the two componentspresents itself. This issue was discussed in U.S. Pat. No. 6,329,564,the disclosure of which is incorporated herein by reference. Briefly, inorder to assemble an interlaced device it may be necessary to constructthe first component and the second component independently, andsubsequently cut one of the two components in order to interleaveconnecting members. The cut can be rejoined using an adhesive backedfilm or tape. Alternatively, at least one of the two components can beincompletely produced enabling interlacing, followed by completion ofthe device (e.g., by the addition of a pulling element).

The adhesive-backed surfaces of the device of the present invention areprotected (e.g., from contamination and oxidation) by the application ofrelease liners during the manufacturing process. In some instances,multiple release liners, or release liner systems may be used to protecta single, uninterrupted, adhesive-backed surface. Consider, for example,the anchoring members of the disclosed device. In order to preciselyattach the wound edge of an anchoring member adjacent a laceration orincision to be closed, it is preferable to hold the anchoring memberwith one hand leaving the other hand free to manipulate the lacerationor incision area. Thus, a plurality of release liners on each anchoringmember is preferred. A first release liner, which protects the woundedge, is removed first during the application process. In this way, aportion of the wound edge can be adhered to the skin while leaving aprotected portion of the anchoring member which can be held (e.g., in agloved hand) without the device adhering to the fingers of the user.Once the wound edge has been applied, the second release liner can beremoved to fully secure the anchoring member. The use of a plurality ofrelease liners in connection with the adhesive associated with theconnecting members is less important as extensions of the connectingmembers and pulling elements are provided “adhesive-free” in preferredembodiments. To minimize confusion for new users of the device of thepresent invention, the release liners may be also be coded. Releaseliner colors or printed indicia on the release liner are examples ofcoding enabling a user to readily identify the order of release linerremoval.

As discussed above, the film or sheet stock used to manufacture thefirst and second components of the device of the present invention canbe, and preferably are, extremely thin. When applying an anchoringmember produced from such thin stock next to a laceration or incision,it is easy to imagine difficulties associated with wrinkling andoverlapping of edges, inadvertent or incorrectly positioned initialcontact, etc. The release liners employed in connection with the devicecan provide substantial aid in working with the device, particularly adevice produced from thin sheet stock, if properly selected. Forexample, if two release liners are used to protect the adhesive-backedsurface of an anchoring member, the characteristics of the release linerprotecting the wound edge of the anchoring member is far less importantthan the characteristics of the later-removed, second release linerprotecting the anchoring member. If, for example, a semi-rigid secondrelease liner is employed, this will enable more precise placement ofthe wound edge of the anchoring member.

In developing the device of the present invention, the placement of theinitial components is most important in achieving the best cosmeticresults. A positioning technique which has proven to be effectiverequires the use of alignment indicators on the anchoring members forprecisely placing them and an application technique referred to as“Straightening the Wound Edge” that uses a semi-rigid release liner (orrelease liner system, as discussed below) to apply each anchoring memberfollowing the exposure of adhesive at the wound edge.

As most incisions tend to be almond shaped, the technique is referred toas “Straightening the Wound Edge.” This technique is used as there arefew lacerations having edges that are perfectly straight and the deviceworks best when the edges of a laceration or incision are substantiallystraightened. It has also been demonstrated clinically that all shapedwounds can be segmented into smaller parts that can be closed straightand this provides applicability of the invention by using the devices insequence to all shaped wounds.

Optionally, on each anchoring member, at the midpoint of the wound edge,there is an arrow (or other mark or indicia) referred to as an“alignment indicator” that is used in the placement procedure of thedevice. Such alignment indicators are helpful in positioning theanchoring members.

More specifically, an application procedure is outlined as follows:

-   -   1. Prior to application of the device, the clinician manually        closes the edges of the laceration or incision and places a dot        with a surgical pencil on both sides of the laceration or        incision at the center (the “alignment marks”) about 1/16″ back        from the edge of the laceration or incision. The device can then        be applied.    -   2. Following exposure of the adhesive at the wound edge (e.g.,        by removing a first release liner), the anchoring member is held        between the thumb and middle finger of one hand. The semi-rigid        release liner (or release liner system) is then bent by pinching        the ends together using the thumb and middle finger forcing the        release liner, and the attached anchoring member, including the        wound edge, to adopt a U-shaped conformation. The forefinger can        assist by pushing the midpoint of the wound edge to the bottom        of the U-shaped position. The central portion of the wound edge        (i.e., the portion at the bottom of the U-shaped conformation)        at the alignment indicator is then the first point of contact as        the device is applied to the alignment mark about 1/16″ back        from the wound edge. The device is then manipulated to        straighten the laceration or incision edge, and the remaining        portion of the wound edge is then slowly lowered into contact        with the skin. This step is followed by removal of the remaining        release liner(s) thereby completing the attachment, securing the        remainder of the anchoring member, and achieving a substantially        straight wound edge.

Development of the release liner systems has resulted in a furtherimproved embodiment which is described herein as a two-stage releaseliner system referred to as the “flip tab”. This system provides anumber of advantages which will be discussed in detail. The two-stagerelease liner system includes a single release liner with a bottomsurface covering the entire adhesive-backed surface of an anchoringmember. Attached to the exposed surface of the wound edge portion of therelease liner protecting the wound edge is a semi-rigid tab having afirst and a second edge. The first edge is substantially linear andoriented generally parallel to the wound edge of the anchoring memberand attached to the release liner at a position intermediate in therelease liner between the portion of the release liner protecting thewound edge and the portion of the release liner protecting the edge ofthe anchoring member generally opposite the wound edge. The second edgeof the tab extends unattached beyond the wound edge. To attach ananchoring member protected by the flip tab two-stage release linersystem, a user simply contacts the portion of the semi-rigid tabextending beyond the wound edge (e.g., with a thumb), and while holdingthe component (e.g., by the connecting members attached to the anchoringmember to be applied), flips back or folds the semi-rigid tab (andattached release liner) over onto the portion of the release liner whichis not attached to the semi-rigid tab. This provides for exposure of theadhesive at the wound edge, as well as for the handling advantagesdiscussed above which are provided by the association of the semi-rigidtab with the anchoring member during the placement of the wound edge.When the placement of the wound edge is complete, the semi-rigid tab isgrasped between the thumb and forefinger and pulled, thereby removingthe entire release liner.

With respect to the flip tab two-stage release liner system, it isimportant that when the semi-rigid tab is flipped-back onto the portionof release liner to which it is not attached by adhesive, that theportion of the release liner to which the tab is not attached remainsfully adhered to the anchoring member. During the development process,it was discovered that many of the release liners employed did not foldover cleanly as the tab was flipped back. When using release linersexhibiting this characteristic, it is desirable to crease the releaseliner in the area of the release liner which is not attached to the tab,immediately adjacent the tab, to create a hinge region. Release linersthat did not perform in the desired manner proved to work exceptionallywell following the application of the crease. The crease can be appliedin any number of ways which will be apparent to one skilled the art.When working on a small scale in the development process it wassufficient to run a dull knife down the release liner using the attachedsemi-rigid tab as a guide.

It will be recognized that the two-stage release liner system disclosedherein finds application in connection with products other than thedisclosed laceration closure device. The system can be employed inconnection with any adhesive-backed surface which is protected by arelease liner. In the most general form, the two-stage release linersystem includes a release liner with a bottom surface covering theadhesive-backed surface of an article. A tab is attached to a portion ofthe top surface of the release liner, the tab comprising a first and asecond edge. The first edge of the tab is substantially linear andattached to a portion of the release liner, the second edge extendsbeyond the boundary of the adhesive-backed surface.

The embodiments of the device discussed above comprise first and secondcomponents which are monolithic in nature. That is, the first component(which includes an anchoring member and one or more connecting members)is produced from a single sheet of stock material without joints orseams. The same statement applies to the second component. In analternative embodiment, the first and second components are notmonolithic in nature. This alternative embodiment is based on therecognition that the desired physical properties of the anchoringmembers and the connecting members are not, in every instance,identical. For example, a degree of elasticity is a desirable feature inan anchoring member when applied, for example, to an area such as ajoint. An anchoring member produced from a film having a degree ofelasticity is less likely to release prematurely than an anchoringmember produced from a substantially inelastic material when applied tosuch an area. Elasticity is a property to be avoided when producingconnecting members. Any stretching of connecting members is to beavoided as this will tend to allow premature opening of a laceration orincision.

In embodiments in which the first and second components are notmonolithic, anchoring members may be produced from stock having a degreeof elasticity. Connecting members are produced separately from stockwhich is substantially inelastic. One ore more first connecting membersare then attached (e.g., with adhesive) to a first anchoring member toproduce a first component. A second component is similarly constructed.

It is not a requirement that connecting members and anchoring members ofnon-monolithic components be produced from different stock material. Itmay be desirable, for example, to create an overlap in a portion of theconnecting members (e.g., the bridging portion) in order to provide foradditional strength. Thus, double-thickness in the bridging area may beprovided by producing a monolithic anchoring member including a portionof connecting member. A separately produced connecting member is thenattached, in an overlapping manner, to the monolithic anchoring member.This creates a first component which is double-thick in the bridgingportion for additional strength and further eliminates stretching.

It may be desirable to reinforce the wound edge portion of the anchoringmember with another layer of less flexible stock. This “wound edge bar”would provide better translation of the force applied by the connectingmembers uniformly along the entire wound edge. Similarly, it may bedesirable to reinforce the optional pulling element, or a portionthereof, with another layer of less flexible stock. This “pull bar”would be useful in applying uniform tension from the pulling element toall connecting members, as the device is positioned for closure. Thisfeature would become more important in embodiments of the deviceintended to close long lacerations or incisions where there might be upto four or more connecting members to be pulled and secured to eachanchoring member.

The present invention also relates to methods for closing a lacerationor incision using a device of the type described above. Such methodsinclude the steps of applying the anchoring member of a first and secondcomponent on opposing sides of a laceration or incision to be closed.The laceration is then closed by the user either by pushing the edges ofthe laceration together by manipulating the skin in the area of theanchoring members, by pulling the laceration closed using connectingmembers (or extensions of connecting members, or pulling elements, ifpresent), or by some combination thereof. Once the laceration is closed,the position of the first and second component relative to each other isfixed by attaching the connecting members to the anchoring members.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view illustrating the two components of a device of thepresent invention in a non-applied state.

FIG. 2 is a top view illustrating the two components of a devicefollowing application.

FIG. 3 is a top view illustrating an alternative embodiment of thedevice of the present invention, following application, in which theaverage width of the bridging portion of the connecting members is lessthan the average width of the attached portion of the connectingmembers.

FIG. 4 is a top view illustrating an alternative embodiment of thedevice of the present invention, following application, in which theaverage width of the bridging portion of the connecting members is lessthan the average width of the attached portion of the connectingmembers.

FIG. 5 is a top view illustrating one component of a two-componentdevice of the present invention with optional pulling tab and connectingmember extensions.

FIG. 6 is a bottom view of one component of a two-component device ofthe present invention illustrating an anchoring member protected by aplurality of release liners.

FIGS. 7A and 7B represent a bottom view of one component of atwo-component device of the present invention illustrating a flip-tabtwo-stage release liner system in use. FIG. 7C illustrates an end viewof this embodiment.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The two components (12 and 14) of a two-component device of the presentinvention (10) are shown in FIG. 1. First component (12) includes ananchoring member (16) and a plurality of connecting members (18)extending from a first edge of the device (20) which is also referred toherein as the wound edge. Similarly, the second component (14) includesan anchoring member (17) and a plurality of connecting members (19)extending from a first edge (21) of the device which is also referred toas a wound edge. Anchoring members (16 and 17) have a lower surface (notshown in FIG. 1) which is coated with an adhesive suitable forattachment of the components to the skin. In preferred embodiments, aportion of the lower surface (not shown in FIG. 1) of connecting members(18 and 19) are coated with an adhesive for attachment of the connectingmembers of one component to the anchoring member of the secondcomponent. An incision (22) is also shown in an open state.

Referring to FIG. 2, the device of the present invention (10) is shownin the applied state with the two anchoring members (16 and 17) beingattached to the skin and connected to one another by connecting members(18 and 19). A closed incision (22) is also shown in FIG. 2. The portionof the connecting members (18 and 19) spanning the over-laceration areabetween the anchoring members (16 and 17) is referred to as the bridgingportion, and the portion of the connecting members (18 and 19) which isattached to the anchoring member of another component is referred to asthe attached portion. Wound edges of the device 20 and 21 are also shownin FIG. 2. The bridging portions and attached portions may be moreclearly shown in FIG. 3 which follows.

Referring to FIG. 3, anchoring members (16 and 17) having wound edges(20 and 21) are shown in the attached state on opposing sides of anincision (22). Bridging portions (24) and attached portions (26) ofconnecting members are most readily seen is this drawing. In theembodiment depicted, the average width of the bridging portions (24) isless than the average width of the attached portions (26). In thisembodiment, the average width of the attached portions (26) issubstantially constant, whereas a narrowing cut is made to form thebridging portions (24). It should be noted that in the embodiment shown,a right angle cut defines the junction between the bridging portion (24)and anchoring member (16). In preferred embodiments, however, such rightangle cuts are to be avoided as this can create points of weakness inthe device. Thus, in preferred embodiments, the right angle cut at thejunction between bridging element (24) and anchoring member (16) isreplaced with a shouldered cut, such as the 45 degree cut shown at thejunction between bridging portion (24) and attached portion (26).

Referring to FIG. 4, a second embodiment in which the average width ofthe bridging portions (24) is less than the average width of theattached portions (26) is shown. Also shown are anchoring members (16and 17) having wound edges (20 and 21). Incision (22) is shown in theclosed state. In the embodiment depicted in FIG. 4, the anchoringmembers (26) are flared to provide additional adhesive contact therebyproviding for increased security of closure.

Referring to FIG. 5, a single component (12) of a two-component deviceof the present invention is depicted. The device includes an anchoringmember (16) and a plurality of connecting members (18) having a bridgingportion (24) and an attachment portion (26). Shown in FIG. 5 areoptional extensions of connecting members (28), optional pulling elementconfiguration (30), and optional perforations (31) for removal ofextensions of connecting members (28) and pulling element (30). Alsoshown in FIG. 5 are optional wound edge bar (44), pull bar (46), andalignment indicator (48).

FIG. 6 is a bottom view of one component of a two-component device ofthe present invention illustrating an anchoring member (16) protected bya first release liner (32) and a second release liner (34). The firstrelease liner (32) protects the adhesive at the wound edge (20) of theanchoring member (16). In use, the first release liner (32) is removedfirst and the wound edge (20) is applied to the skin. The presence ofthe second release liner (34) allows a user to hold the device whilepositioning the wound edge (20). In the preferred embodiment, therewould be removal tabs to facilitate the removal of each liner that wouldbe clear to one skilled in the art.

FIGS. 7A and 7B represent a bottom view of one component of atwo-component device of the present invention illustrating a flip-tabtwo-stage release liner system. As shown in FIG. 7A, the adhesive-backedsurface of anchoring member (16) is covered by a release liner (36). Asemi-rigid tab (38) is attached to the release liner (36). A first edge(40) of the semi-rigid tab (38) is positioned parallel to wound edge(20) and attached to the release liner (36) at a position intermediatebetween the wound edge (20) and a second edge (39) of the anchoringmember (16) generally opposite the wound edge (20). A second edge (42)of the semi-rigid tab (38) extends unattached beyond the wound edge (20)of anchoring member (16). FIG. 7C shows an end view of the deviceillustrated in FIG. 7A which includes semi-rigid tab (38), release liner(36) protecting the adhesive-backed surface of anchoring member (16), aswell as connecting member (18) protected by another release liner (41).As shown in FIG. 7C, the semi-rigid tab (38) and a portion of theattached release liner (36) are folded over, or flipped back onto theportion of the release liner (36) which is not attached to thesemi-rigid tab (38), thereby exposing the adhesive-coated surface ofanchoring member (16) which includes the wound edge (20). The wound edge(20) is then attached to the skin following visual alignment, and thesemi-rigid tab (38) is then gripped and removed, together with theattached release liner (36). Connecting members (18) are also shown withassociated release liners (41).

1. A two-component device for closing a laceration or incision,comprising: a) a first substantially inelastic component comprising afirst adhesive-backed anchoring member and one or more first connectingmembers extending from one edge thereof in a first direction, the firstcomponent being transparent; b) a second substantially inelasticcomponent comprising a second adhesive-backed anchoring member and oneor more second connecting members extending from one edge thereof in asecond direction generally opposite to the first direction, the secondcomponent being transparent; wherein the first component and the secondcomponent are separate and distinct and the one or more first connectingmembers and the one or more second connecting members are interleaved;and c) means for attaching the one or more first connecting members tothe second adhesive-backed anchoring member and means for attaching theone or more second connecting members to the first adhesive-backedanchoring member, the attachment of the one or more first and secondconnecting members to the first and second adhesive-backed anchoringmembers form attached and bridging portions of the one or more first andsecond connecting members, such that the attached portions are attachedto the first and second adhesive-backed anchoring members and thebridging portions span over the laceration area between the first andsecond adhesive-backed anchoring members.
 2. The two-component device ofclaim 1 further comprising a pulling element attached to the one or morefirst connecting members, or extensions thereof, and a pulling elementattached to the one or more second connecting members, or extensionsthereof.
 3. The two-component device of claim 2 wherein the pullingelements of the one or more first and second connecting members and thefirst and second adhesive-backed anchoring members are coded to enableuser distinction.
 4. The two-component device of claim 3 wherein thecoding comprises an observable geometric distinction between the shapeof the pulling elements and the shape of the anchoring members.
 5. Thetwo-component device of claim 3 wherein the coding comprises printedindicia enabling user distinction between pulling elements and anchoringmembers.
 6. The two-component device of claim 3 wherein the codingcomprises distinguishing colors.
 7. The two-component device of claim 2wherein the pulling elements of the one or more first and secondconnecting members and extensions of the one or more first and secondconnecting members are removable following application of the device. 8.The two-component device of claim 2 wherein the pulling element isreinforced with a pull bar.
 9. The two-component device of claim 1 whichis produced from a vapor-permeable material.
 10. The two-componentdevice of claim 1 wherein the means for attaching the one or more firstand second connecting members to the first and second adhesive-backedanchoring members is adhesive, adhesive being applied to at least aportion of the lower surface of the one or more first and secondconnecting members.
 11. The two-component device of claim 10 wherein theadhesive-backed surface of each anchoring member of the first and secondadhesive-backed anchoring members is protected by one or more releaseliners, and the adhesive-backed surface of each connecting member of theone or more first and second connecting members is protected by one ormore release liners.
 12. The two-component device of claim 11 whereinthe release liners are optionally coded to indicate sequence of removal.13. The two-component device of claim 1 wherein the adhesive applied tothe portion of the lower surface of the one or more first and secondconnecting members is protected by a first and a second release liner,the first release liner protecting the adhesive along the edge fromwhich the one or more first and second connecting members extend, andthe second release liner protecting the adhesive along a length of theedge of the respective adhesive-backed anchoring member which isgenerally opposite the edge from which the one or more first and secondconnecting members extend.
 14. The two-component device of claim 13wherein the coding comprises printed indicia enabling user distinctionbetween the first release liner and the second release liner.
 15. Thetwo-component device of claim 13 wherein the coding comprisesdistinguishing colors between the first release liner and the secondrelease liner.
 16. The two-component device of claim 1 wherein the firstand second adhesive-backed anchoring members are provided with one ormore alignment indicators.
 17. The two-component device of claim 1wherein the first and second adhesive-backed anchoring members arereinforced with a wound edge bar.
 18. A method for closing a lacerationor incision, the method comprising: a) providing a two-component devicefor closing a laceration or incision, comprising: i) a firstsubstantially inelastic component comprising a first adhesive-backedanchoring member and one or more first connecting members extending fromone edge thereof in a first direction, the first component beingtransparent; ii) a second substantially inelastic component comprising asecond adhesive-backed anchoring member and one or more secondconnecting members extending from one edge thereof in a second directiongenerally opposite to the first direction, the second component beingtransparent; wherein the first component and the second component areseparate and distinct and the one or more first connecting members andthe one or more second connecting members are interleaved; and iii)means for attaching the one or more first connecting members to thesecond adhesive-backed anchoring member and means for attaching the oneor more second connecting members to the first adhesive-backed anchoringmember, the attachment of the one or more first connecting members andthe one or more second connecting members to the second and firstadhesive-backed anchoring members, respectively, forming attached andbridging portions of the one or more first and second connectingmembers, the attached portions being attached to the respective firstand second adhesive-backed anchoring member, and the bridging portionsspanning the over-laceration area between the first and secondadhesive-backed anchoring members; b) attaching the first and secondcomponents to at least a portion of skin on opposite sides of thelaceration or incision, the edge of the first and second components fromwhich the one or more first and second connecting members extend beingthe edge closest to the laceration or incision; c) closing laceration orincision by adjusting a position of the first and second adhesive-backanchoring members relative to each other in both an X and a Y dimension;and d) fixing the relationship between the first and secondadhesive-backed anchoring members to the second adhesive-backedanchoring member, and the one or more second connecting members to thefirst adhesive-backed anchoring member.
 19. The method of claim 18wherein the device further comprises a pulling element attached to theone or more first connecting members, or extensions thereof, and apulling element attached to the one or more second connecting members,or extensions thereof.
 20. The method of claim 19 wherein the pullingelements of the one or more first and second connecting members isreinforced with a pull bar.
 21. The method of claim 18 wherein the firstand second adhesive-backed anchoring members are reinforced with a woundedge bar.
 22. The method of claim 19 wherein the pulling elements of theone or more first and second connecting members and the first and secondadhesive-backed anchoring members are coded to enable user distinction.23. The method of claim 22 wherein the coding comprises printed indiciaenabling user distinction between pulling elements and anchoringmembers.
 24. The method of claim 22 wherein the coding comprisesdistinguishing colors.
 25. The method of claim 19 wherein the pullingelements of the one or more first and second connecting members andextensions of the one or more first and second connecting members areremovable following application of the device.
 26. The method of claim22 wherein the coding comprises an observable geometric distinctionbetween the shape of the pulling elements and the shape of the anchoringmembers.
 27. The method of claim 18 wherein the device is produced froma vapor-permeable material.
 28. The method of claim 18 wherein the meansfor attaching the one or more first and second connecting members to thefirst and second adhesive-backed anchoring members is adhesive, adhesivebeing applied to at least a portion of the lower surface of the one ormore first and second connecting members.
 29. The method of claim 28wherein the adhesive-backed surface of each anchoring member isprotected by one or more release liners, and the adhesive-backed surfaceof each connecting member is protected by one or more release liners.30. The method of claim 29 wherein the release liners are optionallycoded to indicate sequence of removal.
 31. The method of claim 30wherein the adhesive-backed surfaces of the first and second anchoringmembers each are protected by a first and a second release liner, thefirst release liner protecting adhesive-backed surfaces along the edgefrom which the one or more connecting members extend, and the secondrelease liner protecting the adhesive-backed surfaces along the lengthof the edge of the anchoring member which is generally opposite the edgefrom which the one or more connecting members extend.
 32. The method ofclaim 31 wherein the coding comprises printed indicia enabling userdistinction between the first release liner and the second releaseliner.
 33. The method of claim 31 wherein the coding comprisesdistinguishing colors between the first release liner and the secondrelease liner.
 34. The method of claim 18 wherein the first and secondadhesive-backed anchoring members are provided with one or morealignment indicators.